FDA Adverse Event Injury Summary report: N

TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

MDR report key: 17515676 · Received August 11, 2023

Report

Report Number: 3010355846-2023-00094
Event Type: Injury
Date Received: August 11, 2023
Date of Event: November 5, 2021
Report Date: August 11, 2023
Manufacturer: OUTSET MEDICAL, INC.
Product Code: KDI
PMA / PMN Number: K190793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE (IFU) WITH THE TABLO SYSTEM INCLUDES, BUT ARE NOT LIMITED TO, OTHER, MORE SERIOUS, COMPLICATIONS ARISING FROM DIALYSIS, SUCH AS HEMORRHAGE, AIR EMBOLISM, ACIDOSIS, ALKALOSIS OR HEMOLYSIS, CAN CAUSE SERIOUS PATIENT INJURY OR DEATH. TABLO USER MANUAL HAS THE FOLLOWING WARNING: CHECK ALL BLOODLINES FOR LEAKS AFTER THE TREATMENT HAS STARTED. KEEP ACCESS SITES UNCOVERED AND MONITORED. IMPROPER BLOODLINE CONNECTIONS OR NEEDLE DISLODGEMENTS CAN RESULT IN EXCESSIVE BLOOD LOSS, SERIOUS INJURY, AND DEATH. MACHINE ALARMS MAY NOT OCCUR IN EVERY BLOOD LOSS SITUATION. OUTSET MEDICAL, INC. TECHNICAL SERVICE ENGINEER (TSE) FOUND NO ISSUE WITH THE CONSOLE AND CONSOLE OPERATED AS INTENDED. FURTHERMORE, CONSOLE HAS BEEN USED IN SUBSEQUENT TREATMENT. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER RETROSPECTIVE REVIEW AND REASSESSED AS REPORTABLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE HOME PATIENT WAS "MIS THREADED", WHICH THE NURSE BELIEVED CAUSED A SLOW LEAK OF BLOOD TOTALING APPROXIMATELY 1L OF BLOOD LOSS. THE HOME PATIENT TOOK SEVERAL BOLUSES OF FLUID TO REMEDY AND TREATMENT ENDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
869833	TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	OUTSET MEDICAL, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other